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Set-up, operate, and disinfect pharmaceutical manufacturing equipment including autoclaves, depyrogenation tunnels, vial washers, parts washers, VHP systems, automated filling lines, cappers, vision inspection systems, and lyophilizers.
• Perform sanitization, disinfection, and cleaning of equipment, barriers, and GMP areas.
• Perform routine troubleshooting and corrective/preventative maintenance on process equipment.
• Visually inspects parenteral products
• Write and maintain standard operating procedures (SOPs) for manufacturing equipment.
• Assist with validation, change controls, and quality investigations
• Actively participates in GEMBAs, & RCAs; contribute to a continuous improvement culture
• Actively participates in the safety program and live the Living Safety culture
• Performs assigned Line Clearance activities
• Assist Product Teams in process development with issues related to aseptic processing technology or sterile manufacturing equipment.
• Provides technical training for new or less experiences team members.
• Perform all work in strong alignment with the Behavior Expectations
• Notify supervisor immediately of any quality or safety risks or concerns.
• Minimum High School Diploma; additional technical training and/or certification preferred
• Minimum 3 years of experience working in a clinical scale aseptic manufacturing environment, or equivalent.
• Good written and oral communication skills, including proficiency in MS Office.
• Proven teamwork and organizational skills, including demonstrated leadership ability.
• Ability to function independently.
• Experience in the hands-on use of equipment and processes to manufacture sterile drug products.
• Experience visually inspecting parenteral products.
• Thorough knowledge of and experience working with cGMP and documentation principals for the manufacture of sterile drug products, or similar highly regulated environment.
• Strong knowledge of aseptic techniques and sterility assurance in aseptic processing.
• Basic knowledge of microbiology as it relates to sterile manufacturing.
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.